Reducing COVID-19 Related Disability in Rural Community-Dwelling Older Adults Using Smart Technology

February 28, 2024 updated by: Rachel Proffitt, University of Missouri-Columbia
The social distancing requirements for COVID-19 coupled with the adverse health impacts of social isolation and decreased access to healthcare in rural areas places older adults with disabilities in a dire situation. The smart sensor system to be deployed and studied in this project aims to reduce disability for rural community-dwelling older adults and improve health-related quality of life, including depression and anxiety. An implementation guide will be developed to increase success of future scale-up evaluations.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Over 85% of Missouri is rural and individuals in these rural areas are older and have reduced access to regular healthcare as compared to individuals living in urban areas of Missouri. Those with disabilities, particularly older adults, are at higher risk for contracting COVID-19. There is a critical need to reduce disability and improve quality of life for community-dwelling older adults with disabilities for successful aging-in-place during the COVID-19 pandemic. We have developed, with our partner company Foresite Healthcare, a proven sensor-based technology solution for monitoring health-related behaviors in the home. In a multi-site randomized controlled trial, we demonstrated that the sensor system with nursing care coordination prevents declines in function for older adults living in assisted living facilities. The long-term goal of this research is to support independent living for older adults with disabilities for as long as possible. The purpose of this project is to deploy the sensor system in the homes of rural community-dwelling older adults with disabilities and evaluate the effect of the sensor system on reducing disability and improving health-related quality of life. Using a two-arm randomized controlled trial, the sensor system will be installed in the homes of 64 older adults. Participants randomized to Study Arm 1 will receive a multidisciplinary (nursing, occupational therapy, and social work) self-management intervention paired with the sensor system. This intervention is based on the 5As self-management approach and is a direct translation of the nursing care coordination in our prior research. Participants randomized to Study Arm 2 will have standard health education paired with the sensor system. An implementation guide for future use with different partner agencies will be developed using individual and setting level data collected from Aims 1, 2 and 3 using the RE-AIM framework. The project will be accomplished in three aims. In Aim 1, we evaluate the effect of a sensor system paired with a multidisciplinary self-management intervention as compared to the sensor system paired with standard health education care on disability and health-related quality of life after 1 year. In Aim 2, we will evaluate the effect of the sensor system on secondary health outcomes (depression, anxiety, occupational performance, and caregiver burden), rates of falls, and healthcare usage. In Aim 3, we will collect individual participant data for satisfaction and adoption and stakeholder data about organizational setting. Data from Aims 1, 2 and 3 will be analyzed using RE-AIM to produce implementation guidance contextualized by organizational setting. For older adults with disabilities living in rural areas, the sensor system has the potential to change the approach to healthcare and disability management.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65211
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Over the age of 65, Live in a rural defined county, Have difficulty with at least 1 self-care task or 2 daily living tasks, Have internet access, Able to stand with or without assistance

Exclusion Criteria:

  • Life expectancy less than one year, Severe cognitive impairment (mini mental state exam score <17), Life in a facility that provides care services, Katz ADL Score of 6, Receiving in-home physical therapy, occupational therapy or nursing, Have been hospitalized more than three times in teh previous 12 months, Plan to change residences within the next year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self Management
The 5A's Behavior Change Mode [39] is the framework for the self-management intervention. The five "A"s will be addressed through the integration of the self-management intervention and the sensor system. There will be a minimum of four intervention sessions with each healthcare profession (OT, RN, and SW) for 12 visits per participant.
Behavioral: Self Management
The self-management intervention will be delivered over the course of a year. There will be a minimum of four intervention sessions with each healthcare profession (OT, RN and SW) for 12 visits per participant. The team (OT, RN and SW) will meet twice during the first 2 months to determine a lead interventionist based on the participant's SMART goals and areas of concern. The lead interventionist will have three additional sessions with the participant and will be the point-person for sensor system alerts and messages. Goal Attainment Scaling [83] will be administered during the quarterly interview to assess participant progress on SMART goals. This measure is administered collectively with the participant, provides further accountability, offers opportunities to the participant for reflection on progress, and is a concrete measure of "success" of the self-management intervention.
Active Comparator: Health Education
Participant's randomized to the standard health education arm will receive the intervention at Month 1 and then months 3, 6, 9 and 12.
Behavioral: Standard Health Education
Participants randomized to the standard health education arm will receive the intervention at month 1 and then months 3, 6, 9, and 12 (coinciding with the quarterly interviews). The participant will use the tablet and telehealth platform to complete the interview and education session with research staff. The content of these sessions will be focused on helping the participant (and family member/caregiver as appropriate) understand their health data, assisting them with any technology issues and providing the participant with education on their condition(s) and any requested resources. Research staff will will also provide any additional health education if there are changes to conditions or new diagnoses after an outside provider visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Katz ADL Index
Time Frame: 1 year
Disability
1 year
Change in PROMIS-29
Time Frame: 1 year
Health-related quality of life
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hospital Anxiety and Depression Scale
Time Frame: 1 year
Depression and anxiety
1 year
Change in Canadian Occupational Performance Measure
Time Frame: 1 year
Occupational performance
1 year
Change in Patient Activation Measure
Time Frame: 1 year
Patient activation/self-efficacy
1 year
Technology Experience Profile
Time Frame: Baseline
Experience with technology
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Rachel M Proffitt, OTD, University of Missouri-Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

March 21, 2022

First Submitted That Met QC Criteria

May 16, 2022

First Posted (Actual)

May 18, 2022

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2043542
  • 1R01AG072935-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We will share de-identified clinical outcome data and parameters extracted from the sensor system (e.gs., motion density, gait speed) associated with the study participants by depositing these data at the National Archive of Computerized Data on Aging (NACDA) which is an NIH-funded repository. Submitted data will confirm with relevant data and terminology standards. Data will be de-identified following the University of Missouri IRB procedures. All sensor parameters are stored on the secure server as de-identified data so no further processing will be required before depositing at NACDA. Identifiers will be removed from clinical outcome data before depositing at NACDA. All personal and private information of study participants will be protected using our secure data collection system (RedCap) on an encrypted network. No personal or private information will be shared.

IPD Sharing Time Frame

Data will be available at the completion of the study and will be held according to parameters for the National Archive of Computerized Data on Aging (NACDA)

IPD Sharing Access Criteria

As I will be using National Archive of Computerized Data on Aging (NACDA), which is an NIH-funded repository, this repository has policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Clinical Trials on Self Management

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe